Manager - Quality Control (Investigation)

Roles and Responsibilities

• Conduct quality control investigations to identify root causes of deviations, non-conformities, and out-of-specifications.
• Review and investigate complaints related to product quality, stability, or efficacy.
• Prepare investigation reports detailing findings and recommendations for corrective actions.
• Investigate the reported OOS, OOT, Deviations and Market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA.
• To review and improve quality of investigations of other investigation members in terms of technical report writing skills as per format.
• To provide support to site during regulatory inspection or audits / Inspections conducted by local regulatory bodies / vendors / third parties, for related investigation.
• Practical knowledge and troubleshooting skill of various analytical instruments like HPLC, GC, KF, XRD, PSD by Malvern, UV etc.
• Person should have exposure of analysis of solid oral dosage form or Opthalmic dosage.
• Well versed in cGMP, GxP practices.
  
  

Desired Candidate Profile

• 15-18 years of experience in Quality Control (Investigation) role in pharmaceutical industry.
• Stability of working minimum 3 years in each organization.
• Bachelor's degree in pharmacy (B.Pharma) or Master's degree in science (MS/M.Sc).
• Excellent analytical skills with ability to interpret data from various sources.